Recall of Device Recall Mevatron KD2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Linear Accelerator - Product Code IYE
  • Reason
    Radiation leak: when used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of iec standards.
  • Action
    Siemens sent a Customer Safety Advisory Notice dated 12/12/2007 to DEVA customers. The letter stated that Siemens would temporarily disable energies 5MeV and below for all customers that decide to continue using the DEVA, resulting in the temporary unavailability of energies 5MeV and below for all available. Customers wishing not to have these energies blocked must return their DEVA and they would be contacted by a local Siemens rep to schedule a service appointment. The letter stated that as a preventative measure that those customers should refrain from using the DEVA with any combination of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fixed field electron applicators and cutouts with these energies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing the use of lower energies using the fixed field electron applicatiors.


  • Model / Serial
    Serial numbers:3041 2451 2525 2547 2575 2582 2589 2602 2667 2726 2769 2781 2801 2952, and  2571
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution: USA, Canada, Belgium, Bulgaria, France, Germany, Hungary, India, Italy, Japan, Malaysia, P.R. China, Pakistan, Poland, Portugal, Qatar, Republic Korea, South Africa, Spain, Sweden, and United Kingdom.
  • Product Description
    Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
  • Manufacturer


  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source